34 Participants Needed

PET/MR Imaging for Cardiac Arrhythmias

MN
Overseen ByMarc Normandin
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is performed to assess if PET-MR imaging can improve treatment of patients with irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One category of irregular heart rate is called ventricular arrhythmia. It is often seen in patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation does not fix the problem in 100% of patients and some will still have the arrhythmia requiring repeated procedure. The purpose of this study is to find new ways of guiding the doctors performing ablation, hoping to improve the success rate of the procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is PET/MR Imaging for Cardiac Arrhythmias safe for humans?

The research articles discuss the safety of MRI in various contexts, including patients with cardiac devices and children, but do not specifically address the safety of PET/MR Imaging or 18F-TPP for cardiac arrhythmias. However, MRI is generally considered a safe imaging technique, with specific protocols to minimize risks, especially in patients with certain devices.12345

How does PET/MR imaging for cardiac arrhythmias differ from other treatments?

PET/MR imaging is unique because it combines two advanced imaging techniques to provide a comprehensive view of the heart's structure and function, which helps in diagnosing and managing cardiac arrhythmias. This approach allows for the assessment of myocardial perfusion (blood flow in the heart muscle), inflammation, and sympathetic innervation, offering insights that are not possible with traditional treatments.678910

What data supports the effectiveness of the treatment 18F-TPP for cardiac arrhythmias?

The research highlights the potential of PET/MR imaging in diagnosing and managing cardiac arrhythmias by assessing heart function and structure, which can help in understanding the effectiveness of treatments like 18F-TPP. PET imaging, part of the PET/MR approach, is particularly useful in evaluating heart conditions that may lead to arrhythmias, suggesting that 18F-TPP could be effective in this context.69111213

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 with a history of scar-mediated ventricular arrhythmia who are scheduled for ablation therapy. They must be able to consent and have no structural heart disease, MRI/PET contraindications, severe kidney issues, diabetes, lupus, or certain other conditions. Pregnant or lactating women cannot participate.

Inclusion Criteria

I am between 21 and 80 years old.
Subjects must provide informed consent prior to study procedures
I am scheduled for a procedure to treat irregular heartbeats caused by scar tissue.

Exclusion Criteria

I do not have any health conditions or devices that prevent MRI or PET scans.
I have had irregular heartbeats from the lower chambers of my heart.
I have a heart condition like a previous heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EAM-guided catheter ablation and PET-MR imaging to assess treatment improvement

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after ablation treatment

5 years

Repeat Ablation (if necessary)

Participants with recurrent ventricular arrhythmia undergo a second imaging session and repeated ablation

Varies per patient

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-TPP
Trial Overview The study tests if PET-MR imaging can help doctors perform ablation more successfully in patients with irregular heart rates due to ventricular arrhythmias. The goal is to improve the procedure's success rate and reduce the need for repeat treatments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment FailureExperimental Treatment1 Intervention
Group II: ArrhythmiaExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Cardiovascular magnetic resonance (MR) is a safe, non-invasive imaging technique that is the gold standard for assessing heart anatomy and function, but it is important to understand the safety and contraindications of various metal and electronic devices in patients undergoing MR.
The review highlights potential factors affecting image quality and patient comfort, such as arrhythmias and claustrophobia, and discusses the safety and side effects of gadolinium-based contrast agents used in MR imaging.
Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications.Barison, A., Baritussio, A., Cipriani, A., et al.[2021]

Citations

Potential Role of PET in Assessing Ventricular Arrhythmias. [2019]
Cardiovascular hybrid imaging using PET/MRI. [2022]
Structural and Physiological Imaging to Predict the Risk of Lethal Ventricular Arrhythmias and Sudden Death. [2020]
Diagnosis of cardiac abnormalities in patients with nonischemic tachyarrhythmias: additional value of MR imaging. [2019]
Applications of PET-MR Imaging in Cardiovascular Disorders. [2021]
Free breathing cardiac real-time cine MR without ECG triggering. [2018]
Safety of MRIs in patients with pacemakers and defibrillators. [2022]
Myocardial Stress Perfusion MRI Using Regadenoson: A Weight-based Approach in Infants and Young Children. [2022]
MRI in pediatric and congenital heart disease patients with CIEDs and epicardial or abandoned leads. [2023]
Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Applications of Cardiac MR Imaging in Electrophysiology: Current Status and Future Needs. [2020]
Value of cardiac MRI to evaluate ischemia-related ventricular arrhythmia substrates. [2015]
Feasibility of real-time MR thermal dose mapping for predicting radiofrequency ablation outcome in the myocardium in vivo. [2022]
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